18 to 100 years old
blood, bone marrow, refractory myelodysplastic syndrome, acute myeloid leukemia, cancer, chemotherapy, leukemia
Drug study, Phase 1
You have recurrent or persistent acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). You have already been treated with chemotherapy and your disease is now growing.
Inclusion Criteria: - Subjects with evidence of relapsed or refractory acute myeloid leukemia (AML) or relapsed or refractory myelodysplastic syndrome (MDS) - For subjects with relapsed AML: evidence of >= 5% blasts in the bone marrow or development of extramedullary disease (according to 2003 IWG criteria) who relapse after: - Allogeneic hematopoietic stem cell transplant, or - After one cycle of standard cytotoxic chemotherapy or two cycles of any hypomethylating agent-based therapy - For subjects with refractory AML: =< 2 prior induction regimens (example: patients who receive 7+3 followed by 5+2 would count as one induction regimen) or a minimum of two cycles of any hypomethylating agent-based therapy - For subjects with treatment-naive AML: must be 75 years and older with de novo or secondary AML to be considered eligible - For subjects with relapsed MDS: disease recurrence after CR, partial remission (PR) or hematologic improvement with bone marrow blasts >= 5% who relapse after: - Allogeneic hematopoietic stem cell transplant, or - After four cycles of any hypomethylating agent-based therapy - For subjects with refractory MDS: disease progression at any time after initiation of hypomethylating agent treatment or persistent bone marrow blasts >= 5% despite a minimum of four cycles of hypomethylating agent therapy - Allowed prior allogeneic hematopoietic stem cell transplantation (allo-HCT) regardless of stem cell source; patients must be at least 3 months post allo-HCT (at time of treatment start); mismatched transplantations would be allowed - Patients must be off systemic immunosuppressive medications > 2 weeks prior to treatment start; if patients are in systemic corticosteroids and must be on a dose of prednisone 5 mg/day or less (or equivalent), then patients must be on this reduced dose for > 1 week prior to treatment start; topical steroids are allowed - If post allo-HCT, then patient must have baseline donor T cell chimerism of >= 20% (from peripheral blood); evaluation can be made within 4 weeks of treatment start - No limitations on prior therapies - Eastern Cooperative Oncology Group (ECOG) performance status =< 2 - Total bilirubin =< 1.5 x local institutional upper limit of normal (ULN) - If elevated total bilirubin is due Gilbert's disease or disease-related hemolysis then total bilirubin =< 3.0 x local institutional ULN - Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (SGOT) =< 3.0 x local institutional ULN - Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) =< 3.0 x local institutional ULN - Serum creatinine =< 2.0 x local institutional ULN - Negative serum pregnancy test for women who are of child bearing potential (test must be repeated if performed > 72 hours from treatment start); women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration - Patients with known active human immunodeficiency virus (HIV) infection; patients with chronic HIV with a CD4 > 250, undetectable viral load by PCR, without opportunistic infection, and on a stable regimen of highly active anti-retroviral therapy (HAART) therapy would be eligible - Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria: - Participants who have had chemotherapy or radiotherapy within 2 weeks prior to treatment start or those who have not recovered from adverse events due to agents administered more than 2 weeks prior to treatment start; hydroxyurea is allowed for symptomatic leukocytosis during screening, lead in, and cycle 1 only if clinically necessary; a total white blood cell (WBC) count < 25 x 10^9/L prior to first dose of decitabine on trial is required; prior leukopheresis and/or prior or concurrent treatment with hydroxyurea to achieve this level are allowed - Donor lymphocyte infusion within 8 weeks prior to treatment start - Patients with prior history of severe (grade III or IV) acute GVHD even if resolved - Patients with a history of prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4 antibody), anti-programmed cell death protein 1 (anti-PD 1 antibody), or anti-programmed cell death 1 ligand 1 (anti- PDL1 antibody) - Participants who are receiving any other investigational agents - Participants with known central nervous system (CNS) involvement with leukemia or who are receiving intrathecal chemotherapy that is either prophylactic or therapeutic; history of CNS involvement that has been completely treated (no longer receiving intrathecal chemotherapy) will be allowed - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; if patients are actively being treated with appropriate antibiotics or antifungal therapy with clinical evidence of infection control, then they will be considered eligible for study - Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis); patients with a history of autoimmune disease (specifically including: diabetes mellitus, vitiligo, Hashimoto's thyroiditis) who are asymptomatic, do not require immune suppression or steroids, and do not have threatened vital organ function from these conditions may be considered after discussion with the principal investigator (PI) - No concurrent active malignancies are allowed on study for >= 2 years prior to treatment start with the exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast - Patients with known active hepatitis B virus (HBV) infection should be excluded; however, if a patient has HBV history with an undetectable HBV load by polymerase chain reaction (PCR), no liver-related complications, and is on definitive HBV therapy, then he/she would be eligible for study - Patients with known active hepatitis C virus (HCV) infection; patients with a history of HCV infection who received definitive therapy and has an undetectable viral load by PCR would be eligible - Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ipilimumab
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